Clinical Research Associate (MNC Pharma)

Clinical Research Associate (MNC Pharma)

Conduct site visits, and Phase 1-4 studies, including qualification, initiation, monitoring, and closeout, following protocols, regulatory guidelines, GCP, ICH, and SOPs.

Set up study site management in Veeva Vault CTMS and collect and manage essential documents for assigned sites.

Oversee the activities of clinical investigative sites across multiple protocols.

Oversee site personnel activities to motivate and guide them in meeting study objectives.

Ensure the quality and timely submission of data from study sites.

Collect and upload critical documents into SharePoint, maintaining Permanent Study Files for assigned sites throughout the trial, and prepare, review, submit, and obtain sign-off on Essential Documents Packages (EDP).

Perform on-site product inventory counts and compare with site records to identify discrepancies.

Prepare and submit IRB applications for ethical approval at study sites.

Facilitate Quality Assurance Audits as required.

Ensure regulatory inspection readiness at assigned clinical sites.

Build and maintain professional relationships with study personnel, peers, and office-based staff.

Requirements:

Bachelor’s Degree in clinical science, nutrition, or nursing, or equivalent.

At least 2-3 years of working experience in clinical research / on-site monitoring of investigation products or relevant experience preferred.

Applicant with knowledge of ICH/GCP Guidelines, and applicable local regulations is an added advantage.

Excellent site management and monitoring skills.

Effective communication and problem-solving skills.

For those who have what it takes, please apply online or send in your profile to: